Advancing Health Equity by Improving
Trust in Biomedical Research:
A Community Advisory Board Training
Curriculum for Commissioned Corps’
Health Services Officers
Grace Jama-Adan, MPH, CHES
USPHS COF 50th Annual Scientific and Training Symposium
Track 5 Scientific Program, Macon Room
May 2015
Atlanta, GA
Outline
• Fundamentals of Research Ethics in Biomedical Research
• Incorporating Community Based Participatory Research (CBPR)
into USPHS Biomedical Research Programming
• 2M Timeline for Assembling a Community Advisory Board (CAB)
in your locale of focus
• 1 Day Orientation Training Curriculum for Newly Convened CAB
Biomedical Research & Promotion of Health
Equity
• Health equity=justice and fairness in access and utilization of therapeutic benefits.
• Biomedical research serves as a means of achieving health equitygiving members
of populations with particular disease/risk factors the same access to potentially
therapeutic healthcare
• IRB/IEC oversight of rights, safety, wellbeing of research participants
• RN, PA, NP, PharmD, DDS providers/investigators adhere to Code of Ethics in daily
practice also.
Guiding Principles for Ethical Research Oversight
Belmont Report
Anticipated benefits shall justify
risks/harm (BENEFICIENCE)
New Information provided when
known, both in terms of any
therapeutic advantage or
unanticipated problems (JUSTICE)
Capable study staff
(RESPECT FOR PERSONS)
Good Clinical Practice
IRB/IEC oversight of protocol
compliance
Any medical decisions are made only by
qualified dentist/physician
Subject safety prevails over interests of
science and society
Informed Consent Process
Record Confidentiality/HIPAA
Community perceptions of Research
• What we biomedical research practitioners hope for:
• Treat disease efficiently, effectively, successfully, and
economically, while allowing for some degree of
uncertainty [Cox, 2000]
• Common perception:
• Research done ‘on the community’ versus “with the community”.
• Building a research community- Key Players:
• Public
• Clinicians/Researchers
• Patients/Research Subjects
Community Perceptions of Research:
Informed Decision-Making about Participation
• Relationship building: Forging Relationships with Local Populations
•
•
•
•
•
•
•
•
•
Unsure/uneducated about potential therapeutic benefits
Invasive QoL questionnaires
Being clear about intervention risks (side effects, social risks-time/transportation costs)
Addressing Placebo concerns for RCT
Strong preference for a certain treatment if un-blinded, pre-conceived cohorts on RCT
Clinical equipoise between treatments
Insurance billing issues for certain drugs if perceived as SOC
Fatalism/Escapism Beliefs about Severity of Illness or Risk Factors
Treatment availability after research ends, if indeed gave relief from symptoms
Theory of Community-Based Participatory
Research (CBPR)
Conception
Communication
of Results
Design
Conclusions
Interpretation
Conduct
Analysis
CBPR in Action: Building/Rebuilding Trust
• Co-learning, cyclical, interactive process of community engagement about the
proposed research project.
• Partnership to define health needs and develop health promotion programs,
interventional research, and/or policies.
• Foster collaboration by relying on cooperative respect for community’s voice and
expertise
• Build on existing strengths and resources present in the community’s social structure.
• 2 evidence-based CBPR Methods: CAB and CHW
Community Advisory Board (CAB) Model
• Board members advise investigators on conduct of the biomedical research
being conducted.
• Board members given decision-making autonomy
• CAB can help promote value that USPHS biomedical research is conducted
using quality controls to ensure ethical practice.
• Typical challenges: funding, time to establish and maintain interest
CAB Structure
• 8-10 minimum members who are purposefully selected.
•
•
•
•
•
Houses of worship
Grassroots community organizations with health programming interest
Schools of Public Health
County/city department of health
Neighborhood associations
• Meet 4x/year to address study-specific issues and provide investigators with
feedback
• 1-2 year time commitment of service
• Members aware of duty to ensure the needs of coincide truly coincide with
USPHS research plans. If not, re-work the protocol design/logistics!
• Mission statement/charter that can be changed periodically as needed
Prep Work: Before Community Advisory Board
recruitment outreach
1.
Budget for your CAB development project needs. Allocate funding for venue
booking fees, CAB recruitment flyer printing costs, mileage, refreshments for
training day/open house session.
2. Scout relevant local venues with adequate seating, for at least 15-20 attendees.
3. Brainstorm what the purpose of your CAB with your research team.
4. Draft proposed charter of mission/member expectations/frequency of
meetings, incentives for participation, etc.
5. Understand the history of research in the respective community.
Gantt Chart planning for CAB establishment
9 Week Timeframe to Form a Community Advisory Board
Duration (start date: #days)
TASK (start to finish in descending order)
5-Jun
15-Jun
25-Jun
5-Jul
15-Jul
Identify area stakeholder organizations in locale of interest.
6-Jul
5
Create CAB informational flyers.
6-Jul
5
Send out flyers by mail and email to selected organization's administrative offices.
Followup by phone and/or with in-person appointments with points of contacts at selected organizations
Clarify/streamline purpose of CAB with your USPHS team.
Conduct evening open house meeting.
Finalize board charter (mission, member expectations).
Offer invitations to join CAB to interested, enthusiastic parties.
Conduct CAB qualification 'interviews.'
Train newly diagnosed CAB with a weekend full-day session.
25-Jul
4-Aug
14-Aug
24-Aug
3-Sep
1
11-Jul
7
15-Jul
3
23-Jul
1
1-Aug
3
3-Aug
7
8-Aug
14
15-Aug
1-Sep
1
13-Sep
CAB Establishment Timeline: Identifying
Stakeholders
1) Who are the administrators and/or directors of the selected community
organization?
2) Make contact by phone and email to begin the dialogue about the proposed
project and soon-to-form CAB.
CAB Establishment Timeline: Making the Pitch
1) Distribute informational flyers about the CAB by mail
2) Followup with phone requests for in-person meetings with organization
staff to discuss interest in representation on the CAB.
3) Accept feedback and address any early questions,; clarify the purpose of
the CAB as needed.
CAB Establishment Timeline:
Member Selection/Behavioral Assessments
1.
Conduct the open-house meeting with interested representatives from the
community affiliates. (evening-1hr maximum)
2.
Follow-up after open house with thank you notes for participation, and extend offer
of invitations to join CAB.
3. Finalize pool of interested members.
4. Reach out again by phone to discuss upcoming 1 day weekend training.
5. Ask some behavioral questions to ascertain existing bias towards research, if any.
 Describe your general attitude towards biomedical research.
 How do you feel about friends & close relatives participating in biomedical research?
 Do you think it’s necessary to study new treatments using scientific methods before
they are implemented in clinical practice?
 From where do you think your attitude towards and knowledge about medical
research originates?
1 day Training Rubric for Newly Convened CAB
9am-11am
(Ethical Research
Basics):
12pm-2pm
(Research Logistics)
3pm-5pm
(Recruitment and
Retention)
•
•
•
•
Altruism/common good
Patient involvement in decision-making
Personal benefits of access to regular monitoring and/or chance for a cure
[Break: Networking Brunch for CAB Members]
•
•
•
•
•
•
Ongoing informed consent process
CAB expectations during life of study
Handling subject withdrawal-CAB/investigator communication
Changes to risk-benefit ratio
Randomization basics, if applicable
[BREAK: Focus Group on Study Logistics’ Concerns
•
•
•
•
•
Study Logistics/Research Relevance Script for Recruitment
Brainstorming advertisement strategy
Psychosocial support for participants
“ok to ask” campaign
Trial Conclusion and Results Dissemination
CAB
Formation
Planning (23 months)
Time to
Recruit
Subjects!
Training of
Newly
Established
CAB
Recap
• Healthcare professional governing organizations (AMA, ANA, AAPA, NCHEC)
hold credentialed providers to a set of Code of Ethics for community practice.
• Biomedical research conducted with healthy combination of quality controls
and community input allows us to maintain an ethical professional practice.
• Clinical research can be considered as the intersection of 21st century public
health promotion and academic medicine.
• CAB (Community Advisory Board) implementation is a vital tool for providers
to get buy-in from local stakeholders who are invested in protecting the
community’ values.
• CABs are relatively cost-effective to initiate and maintain, and also help
shape new pathways for trust in biomedical research.
References
 Enhancing Cancer Clinical Trial Management: Recommendations From A Qualitative Study of
Participant's Experiences. (2000). Psycho-Oncology, 314-322.
 Huff, Robert M. (Ed); Kline, Michael V. (Ed). (1999). Promoting health in multicultural populations:
A handbook for practitioners. Thousand Oaks, CA, US: Sage Publications, Inc.
 Madsen, S. H. (2007). Attitudes towards Clinical Research among Cancer Trial Participants and
Non-Participants: An Interview Study Using a Grounded Theory Approach. British Medical Journal,
234-240.
 Manda-Taylor, L. (2013). esing community advisory boards for clinical trial research in Malawi:
engendering ethical conduct in research. Malawi Medical Journal, 96-100.
 Newington, L., & Metcalfe, A. (2014). Researchers’ and Clinicians’ Perceptions of Recruiting
Participants to Clinical Research: A Thematic Meta-Synthesis. J Clin Med Res., 162-172.
 NIEHS. (2000). Successful Models of Community-Based Participatory Research: Final Report.
Washington, DC: National Institutes of Health.
 Sieber, J. (1992). Developing a Research Protocol. In J. Sieber, Planning Ethically Responsible
Research (pp. 142-149). Newbury Park: Sage Publications.
 Tsalikis, J., Seaton, B., & Shepherd, P. (2001). Relativism in Ethical Resarch: A Proposed Model and
Mode of Inquiry. Journal of Business Ethics, 231-246.
For more information….
• Available Handout Today for Future Reference: CE Retention Tool/ Resource
• NIH OBSSR Community Based Participatory Research Index
• Center for Information & Study on Clinical Research and Participation
(CISCRP), Boston, MA www.cisrp.org
• Collaborative Institutional Training Initiative (CITI) Free Trainings in
Biomedical Research/Good Clinical Practice/Responsible Conduct of ResearchCME available www.citiprogram.org
• Feel free to contact me for more information at: gjamaad@emory.edu or
www.twitter.com/docabbygrace
• Reach out to faculty/students/deans of your local Council of Education in
Public Health (CEPH-accredited) school/college of public health for technical
advising and membership recruitment for your CAB www.ceph.org or
www.aspph.org. We are here to help your initiatives!!!